3M’s consumer health care division is voluntarily recalling tens of thousands of ankle braces and supports because they contain undeclared natural latex rubber that could cause allergic reactions in some wearers.
3M has asked retailers to stop selling its Ace Deluxe Ankle Brace and its Futuro Sport Quick Strap Ankle Support, and to arrange for the return of all affected products to 3M, according to recall notices that were publicized Friday by the U.S. Food and Drug Administration.
Specifically, the recalls apply to 162,000 units of Ace braces with the UPC 051131203877, and 158,000 units of its Futuro Sport ankle braces with the UPC 051131196926.
“3M takes the safety of consumers very seriously,” the company said in a statement. “All existing inventory has been placed on hold and is in the process of being over labeled with the appropriate caution statement. ... All affected retail accounts have been notified. Customers will be offered a full credit on returned product.”
The FDA ranked the recalls as Class 2 actions, which are medium-severity actions related to products that might cause a temporary health problem or pose a “slight threat of a serious nature.”
Exposing an allergic person to latex can create symptoms like hives, itching, runny nose, and asthma symptoms like wheezing, chest tightness and difficulty breathing, according to the American College of Allergy, Asthma and Immunology. The most severe allergic reaction can results in anaphylaxis, the organization said on its website.
Although a latex allergy can develop after many previous exposures to latex earlier in life, the symptoms of an active allergic reaction begin within minutes of exposure.
A 3M spokeswoman said the company discovered the labeling problem and notified the FDA.
3M has reported allergic reactions to neoprene-blend rubber in other orthopedic products in the past year to the FDA, but there have been no reports of allergic reactions related to latex with the two recalled products.